We are hiring a Senior Business Systems Validation Engineer to join AbbVie Cork. This role focuses on validation and technical support for manufacturing business systems, particularly MES support for SAP and POMSnet. You will also lead validation activities for the implementation of these systems within the manufacturing environment. In addition, you will support new technology introduction, process improvement, GMP compliance, and troubleshooting throughout the commercial product lifecycle.
What You’ll Do
- Support validation and production activities for MES systems e.g. EBR and SAP, including system upgrades, issue resolution, continuous improvement, and ongoing production support.
- Support SAP and MES activities for new product introductions, including creation of new materials, BOMs, recipes, and system validation.
- Maintain data integrity and data security risk assessments, including support for remediation of legacy systems.
- Support product lifecycle activities, including SOP updates, investigations, study plans, protocols, reports, change plans, annual product reviews, and batch record updates.
- Support the introduction of new products and new technologies, including equipment selection, validation, training, and process support.
- Provide validation guidance for automation and business systems changes, including suitability assessments and VRB assessments where applicable.
- Write and execute validation protocol for , cleaning, equipment, utilities, facilities, automation and process.
- Support change control activities, validation documentation review and approval, and cross-functional project groups.
- Support audit readiness and participate in GMP, corporate, and supplier audits.
- Maintain compliance with cGMP, FDA, IMB, GxP, safety, and environmental requirements.
- Actively contribute to AbbVie’s operational excellence and digital transformation goals by embracing AI tools, data-driven decision-making, and continuous improvement practices.
- Comply with all applicable health, safety, and environmental policies, procedures, and regulations.
- Bachelor’s degree in Engineering, Science, or a related discipline preferred, or equivalent relevant experience.
- 5–10 years’ experience in MES/automation systems validation, new product introduction, and/or manufacturing support within a pharmaceutical or GMP-regulated environment.
- Experience with laboratory and manufacturing equipment validation, computer system validation, GAMP 5, and EU Annex 15.
- Knowledge of process performance qualification, cleaning validation, hold time studies, and validation lifecycle activities.
- Experience supporting ERP SAP systems and MES/EBR implementation.
- Familiarity with data historians such as OSI PI and reporting tools is an advantage.
- Strong project management, problem-solving, and communication skills.
- Ability to work independently and as part of a team, with good people management skills and strong organizational capability.
- Comfortable working under pressure, prioritizing workload, and meeting tight deadlines.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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